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dennis100
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« Reply #30 on: December 15, 2010, 12:01:37 PM »

Model Number 102
Event Date 06/13/2012
Event Type Injury
Manufacturer Narrative

Event Description
Additional manufacturer follow up with the hospital revealed the explanted vns generator was discarded after the surgery.

Event Description
Reporter indicated a patient was experiencing migration of the vns generator into the left axilla, along with painful vns stimulation in the chest. The migration occurred approximately (b)(6) 2012. The patient has also reported the vns lead was migrating, but the reporter confirmed only the generator was migrating. It was also reported the generator was at end of service. However, a battery estimate performed yielded 4 years remaining, indicating end of service is unlikely. The patient had no trauma and did not manipulate the vns. The vns generator was secured with a non-absorbable suture at the initial implant surgery on (b)(6) 2007. Surgery to replace the vns generator is tentatively planned for (b)(6) 2012. Attempts for further information are in progress.

Event Description
Reporter indicated the patient was having some left pectoral pain, but this was not considered a serious injury. It was felt the generator had migrated over the previous 3-4 weeks. The patient had generator replacement surgery performed on (b)(6) 2012. Attempts for return of the explanted generator have been unsuccessful to date.

Manufacturer Narrative
Initial reporter, corrected data: the initial mdr report inadvertently listed the incorrect initial reporter. The correct reporter and occupation are provided.

Event Description
A manufacturer's implant card was received from the reporter indicating that vns device diagnostics were within normal limits with the resident lead and new vns generator at the (b)(6) 2012 surgery. The implant card indicated the generator was replaced for prophylactic reasons.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2648409
« Last Edit: January 30, 2016, 02:45:30 AM by dennis100 » Logged
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« Reply #31 on: December 15, 2010, 12:02:21 PM »

Event Date 04/22/2003
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
Reporter indicated that the pt has been experiencing chest pain and hyperventilation since adjustment of programmed parameters. The pt also complains of left arm pain from the elbow up and having problems cathing the breath when the device stimulates. Investigation to date has been unable to determine whether the chest pain is cardiac-related. The pt contacted the neurologist who instructed to temporarily stop stimulation by placing the magnet over the device for a couple of hours and to call him back for an appointment if the symptoms subsided during that time. Neurologist planned to bring the pt back in for adjustment of programmed parameters if the symptoms subsided when stimulation was stopped with the magnet.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=464839
« Last Edit: February 12, 2015, 11:58:01 PM by dennis100 » Logged
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« Reply #32 on: December 15, 2010, 09:02:09 PM »

Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
Vns patient has experienced a slowed heart rate. The patient had recently been seen by a cardiologist for reasons unrelated to the vns at which time the cardiologist reportedly told the patient that their heart rate was below normal and that is was probably caused by the vns device. The patient reportedly did not notice the abnormal heart rate before their visit with the cardiologist. Treating neurologist indicated that the patient has a history of major psychiatric problems and over using of the magnet which results in chest pain. The patient is reportedly hospitalized for their psychiatric problems at this time. Investigation to date has been unable to determine whether the patient has previous cardiac history.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=484515
« Last Edit: February 12, 2015, 11:58:39 PM by dennis100 » Logged
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« Reply #33 on: December 15, 2010, 09:03:27 PM »

Event Date 01/31/2003
Event Type Injury
Patient Outcome Required Intervention;  
Event Description
Reporter indicated that vns patient had an infection when implanted and was treated with antibiotics. Six months post-operatively, the patient is reportedly scheduled for a surgical consult as it is believed that their incision sites may have not have properly healed. It was later reported that the patient is experiencing a reduction in seizures with the vns therapy, but that they complain of difficulty swallowing, shortness of breath, choking sensation and localized burning sensation with stimulation. The localized burning sensation is reportedly present all of the time but is worse with stimulation. Re-implant is scheduled as the generator has reportedly migrated from below the clavicle to under the arm and the lead wires are protruding under the skin.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=481353
« Last Edit: February 12, 2015, 11:59:18 PM by dennis100 » Logged
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« Reply #34 on: December 15, 2010, 09:04:36 PM »

Event Date 07/01/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization  
Event Description
The reporter indicated that recently the pt began experiencing a sharp pain in the chest when pt "sits down to relax". The pt claims that it doesn't happen at work, it only happens at home, it was also reported that the pt is experiencing painful magnet stimulation. The vns system was evaluated and reported to be functioning properly. The pt was referred to a cardiologist. It was further reported that the device "shocks pt where the implant is" and it only does it at night. The shocking sensation wakes the pt up. X-rays were taken and nothing was seen that could cause the reported adverse event. The reporter also stated that the pt has had the vns implant for approximately 4 years and has had good seizure control. It is unk at this time if the vns system is contributing the pt's chest pain.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=479705
« Last Edit: February 13, 2015, 12:00:07 AM by dennis100 » Logged
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« Reply #35 on: December 15, 2010, 09:05:33 PM »

Event Date 07/01/2003
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
Reporter indicated that vns pt has been experiencing varying heart rate and tightness in the chest. It was reported that the heart beats very fast and then slows down at times with stimulation. It was reported that the pt had been seen by a cardiologist and was wearing a heart monitor for eval of heart rate. Investigation to date has been unable to determine whether the vns therapy was causing or contributing to the pt's varying heart rate.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=479869
« Last Edit: February 13, 2015, 12:01:12 AM by dennis100 » Logged
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« Reply #36 on: December 15, 2010, 09:06:21 PM »

Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that patient's generator was explanted due to chest pain. The patient was reportedly hospitalized for the chest pain approximately six months prior. It was rpeorted that the chest pain did not subside when the device was programmed to off. The patient reportedly had some cardiac issues that may or may not be related to the vns. Treating neurologist indicated that the patient no longer needed the vns therapy as the seizures were being well-controlled with medications. Investigation to date has not been unable to determine whether the patient's pain was cardiac-related.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=476515
« Last Edit: February 13, 2015, 12:01:58 AM by dennis100 » Logged
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« Reply #37 on: December 15, 2010, 09:07:08 PM »

Event Date 07/12/2003
Event Type Malfunction
Event Description
Reporter indicated that vns pt was experiencing an electric pulse at the generator site whenever the device is stimulating. It was reported that the sensation is in the chest area and felt like it was strong to "start their heart if they had a heart attack". Investigation to date has been unable to determine whether a device malfunction has occurred. No serious injury was reported in conjunction with the reported event. The pt temporarily stopped stimulation by taping the magnet over the device until this could be seen by their neurologist for device diagnostic testing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=477077
« Last Edit: February 13, 2015, 12:02:31 AM by dennis100 » Logged
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« Reply #38 on: December 15, 2010, 09:08:04 PM »

Event Date 03/01/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns patient was seen by neurologist for chest pain and increased heart rate. Device diagnostic testing was within normal limits. Normal mode output current was decreased. The patient was seen again the next month and reported no further problems. The increase in heart rate reportedly resolved with the decrease in output current.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=476372
« Last Edit: February 13, 2015, 12:03:16 AM by dennis100 » Logged
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« Reply #39 on: December 15, 2010, 09:08:52 PM »

Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that the pt was experiencing chest tightness. It was also reported that the pt had a seizure recently and pt fell down the stairs and hurt their hand. The pt did not see a physician for the hand. Further follow-up revealed that the physician does not know if the chest tightness is cardiac-related and it was indicated that the pt had not had an ekg done.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=477468
« Last Edit: February 13, 2015, 12:03:50 AM by dennis100 » Logged
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« Reply #40 on: December 15, 2010, 10:32:56 PM »

Event Date 11/22/2003
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that vns pt was hospitalized for two days due to chest pain. It was reported that the pt experienced severe pain at the generator site. The pt experienced the same pain after pt was discharged from the hosp when pt was helping their family member make the bed. The pt starts when pt does activities and that it goes away when pt rests. The pt feels short of breath when pt walks or runs. Further follow-up revealed that device diagnostic testing performed approx one month prior to initial report was within normal limits. Treating neurologist indicated that the pt has experienced no further episodes of chest pain or dyspnea and that the relationship between the reported events and the ncp system was unknown. The pt has been referred to their primary care physician for cardiac work up to rule out cardiac cause.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=503150
« Last Edit: February 13, 2015, 12:04:34 AM by dennis100 » Logged
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« Reply #41 on: December 15, 2010, 10:33:37 PM »

Event Date 11/24/2003
Event Type Malfunction
Event Description
Vnd pt experienced an episode of erratic stimulation while watching television. The erratic stimulation was described as "several random magnetic stimulations", it was reported that the pt was not near any electrical devices or anything that had a large magnetic field. The pt reportedly placed the magnet over the device to stop stimulation, but stimulation reportedly continued. The erratic stimulation continued through the next day. The pt also reported that they had been having chest pains and breathing problems for a few weeks prior to the erratic stimulation event. The chest pain does not coincide with stimulation but stimulation reported makes that chest pain worse.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=506004
« Last Edit: February 13, 2015, 12:05:16 AM by dennis100 » Logged
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« Reply #42 on: December 15, 2010, 10:34:22 PM »

Event Date 11/22/2003
Event Type Malfunction
Patient Outcome Life Threatening;
Event Description
Vns pt had experienced 5 hours of continuous pain at the generator site and felt as if the device was shocking. The pt reportedly placed the magnet over the device to stop stimulation, but the pain did not resolve. It was reported that the pt lives 1/2 mile from some high power lines and has lost use of home phone due to the power lines. The pt also reported some problems with depth perception and memory loss, but thought that these symptoms may be medication-related. Further follow-up revealed that the pt later experienced an increase in pain and an increase in seizures. Investigation to date has been unable to determine whether the device is functioning properly or whether the increase in seizures is above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=505129
« Last Edit: February 13, 2015, 12:06:06 AM by dennis100 » Logged
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« Reply #43 on: December 15, 2010, 10:35:06 PM »

Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Pt is experiencing painful stimulation, but the device was programmed to off over a year ago. It was reported that the pt's device continues to stimulate even after being programmed to off. It was also reported that the pt experienced decreased heart rate (64 bpm) when the device was on. The pt's hands reportedly turned purple and cold during these episodes. It was reported that the pt's heart rate decreased further (40 bpm) after the device was programmed to off. Treating neurologist reportedly does not believe that the pt's symptoms are related to the vns. Cardiologist has reportedly inquired about when the vns would be explanted as they reportedly believed that the pt's symptoms could be related to the device. It was reported that the cardiologist instructed the pt to drink gatorade which seemed to help. Reporter also indicated that the pt had a tumor in their neck.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=500268
« Last Edit: February 13, 2015, 12:07:20 AM by dennis100 » Logged
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« Reply #44 on: December 15, 2010, 10:35:56 PM »

Event Date 10/01/2003
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
Reporter indicated that vns pt was experiencing an increase in heart rate and a feeling that the device "was shocking their heart". Programmed output current had recently been increased to 2. 5ma. Further follow-up revealed that the pt was no longer experiencing the aforementioned symptoms and that no intervention was taken. Treating neurologist indicated that the relationship between the vns and the pt's symptoms was unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=496986
« Last Edit: February 13, 2015, 12:07:56 AM by dennis100 » Logged
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« Reply #45 on: December 15, 2010, 10:36:45 PM »

Event Date 10/01/2003
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that pt has been experiencing heart palpitations. The pt did not know whether the heart palpitations coincided with stimulation. It was reported that the palpitations began within a few weeks of parameter increase. The pt has reportedly been seen by their neurologist since the palpitations began, but no intervention has been taken to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=497015
« Last Edit: February 13, 2015, 12:08:37 AM by dennis100 » Logged
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« Reply #46 on: December 15, 2010, 10:37:30 PM »

Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Patient's device was scheduled to be programmed to off due to swallowing difficulties and shortness of breath until a later time when different programming parameters may be tried. It was reported that the patient experienced a "weird feeling" with stimulation a few months prior during which they could feel the stimulation going from back to neck when the device cycles. This feeling reportedly went away but is now happening again. The patient reports that body gets numb on the left side including face and neck. This feeling does not occur with every stimulation cycle, but only on occasion.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=493439
« Last Edit: February 13, 2015, 12:09:33 AM by dennis100 » Logged
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« Reply #47 on: December 15, 2010, 10:38:14 PM »

Event Type Malfunction  
Event Description
Reporter indicated that pt's device "went off full blast" causing severe pain approximately one minute after being lightly hit in the chest in the area of the device. It was reported that the device continued to stimulate this way every 30 seconds for ten minutes until the pt could get to a magnet and use it to stop stimulation. Further follow-up concluded that the event has not occurred again.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=493646
« Last Edit: February 13, 2015, 12:10:05 AM by dennis100 » Logged
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« Reply #48 on: December 15, 2010, 10:38:52 PM »

Event Date 09/12/2003
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention  
Event Description
Reporter indicated that after an increase in device output current, vns patient's device was programmed to off due to chest pain, dyspnea, tremors and hospitalization for an increase in seizures. It was reported that the day after the device output current was increased, the non-verbal patient began grabbing their chest, sticking their hands in their throat and crying all night. Device output current was reduced three days later from 1. 25ma to 1. 0ma in an effort to resolve the patient's symptoms. The patient's condition has reportedly improved. It was reported that the patient's family member claimed that the vns caused excessive sleepiness and the patient was better within two hours of discontinuing stimulation. Treating neurologist indicated that the incident was possibly related to the vns and that if not related, the possible causes were progression of neurological condition and drug toxicity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=489060
« Last Edit: February 13, 2015, 12:10:44 AM by dennis100 » Logged
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« Reply #49 on: December 16, 2010, 12:47:07 AM »

Event Date 02/27/2004
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that vns pt experienced a strong stimulation while working near a laser that suddenly caused shortness of breath, coughing and pain in left shoulder and arm. The strong stimulation reportedly lasted for about one minute. The pt reportedly works as a service technician with electronic equipment such as computers, robots and laser equipment. When the pt arrived at the hospital an hour later, they were reportedly in shock as well as tired and worried. The pt was so tired that they could not walk from the emergency room to the department of neurology. After arriving in the neurology department, the pt swiped their device with the magnet resulting in 30 seconds of stimulation with severe coughing. The magnet was then placed over the device and stimulation reportedly stopped, as expected. Upon removing the magnet, normal mode stimulation cycles resumed and the pt reported that they could not feel the stimulation. The pt indicated that they do not normally feel normal mode stimulation. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator was not at end of service. Treating physician believes that the magnetic field surrounding the laser equipment caused an activation of the stimulator.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=517908
« Last Edit: February 13, 2015, 12:13:10 AM by dennis100 » Logged
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« Reply #50 on: December 16, 2010, 12:47:53 AM »

Event Date 02/19/2004
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt experienced feelings of heart fluttering and light-headedness while using a microwave. It was reported that the pt had been microwaving several dishes (approximately 6 plates of food, approximately 3 minutes each) when pt experienced light-headedness, irregular heartbeat and a fluttering feeling in their heart that made pt have to go lie down. The pt has a pre-vns history of heart murmur, chest pain and irregular heartbeat, but what pt felt while using the microwave was different. The pt plans to follow-up with their neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=517933
« Last Edit: February 13, 2015, 12:14:20 AM by dennis100 » Logged
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« Reply #51 on: December 16, 2010, 12:48:30 AM »

Event Type Malfunction
Event Description
Reporter indicated that the pt believes that their device may be malfunctioning. It was reported that the pt feels as if their generator is stimulating at higher output current than it is programmed to and at random times. These higher, random, stimulations reportedly cause the pt's heart to race and they become nauseated. The pt did not believe that the events were due to inadvertent magnet mode activations. The pt reports experiencing improved seizure control with the vns therapy. The pt had an appointment to follow-up with their neurologist, but did not go to their scheduled appointment.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=538796
« Last Edit: February 13, 2015, 12:15:16 AM by dennis100 » Logged
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« Reply #52 on: December 16, 2010, 12:49:08 AM »

Model Number 101
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that pt was experiencing chest pain and constant shortness of breath, not associated with stimulation. The pt also indicated that their neck was swelling and puffing out at the lead site. The pt has been seen in hospital emergency room and no infection was noted. The pt is receiving efficacy from the vns therapy, but has had trouble with their body rejecting implants and is considering having the generator moved to the right side of their chest.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=515685
« Last Edit: February 13, 2015, 12:16:15 AM by dennis100 » Logged
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« Reply #53 on: December 16, 2010, 12:49:53 AM »

Event Date 01/01/2004
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that vns pt has recently experienced night-time seizures, which pt apparently never had prior to implant. The pt experiences painful stimulation with the night-time seizures and reportedly has chronic ear, neck and chest pain due to the vns. The pt's device was programmed to off with plans to possibly explant to check for scar tissue and proper device function. Will possibly reimplant with newer model.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=515411
« Last Edit: February 13, 2015, 12:17:05 AM by dennis100 » Logged
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« Reply #54 on: December 16, 2010, 12:50:36 AM »

Event Date 01/01/2004
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that vns pt has complained of a continuous "prickly, sticky, warm pain" at the generator site for approximately 4 weeks. The pain does not coincide with stimulation and the generator site appears to be intact with no swelling or redness. The pt has reportedly experienced efficacy with the vns therapy. The pt went to urgent care center due to the pain and was seen the next day by treating epileptologist. Chest x-rays reviewed by treating epileptologist revealed no discontinuities in the ncp system. Device diagnostic testing was within normal limits, indicating proper device function. The pain reportedly subsided when the device was programmed to off. Treating epileptologist plans to bring the pt back into his office and program the device back to on with some adjustments to device settings to see if the difference in settings will alleviate the pain. Investigation to date has been unable to determine the cause of the pt's pain.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=513425
« Last Edit: February 13, 2015, 12:18:07 AM by dennis100 » Logged
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« Reply #55 on: December 16, 2010, 12:51:24 AM »

Event Date 01/20/2004
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt was experiencing heart palpitations. The pt was seen by a different neurologist than usual as their treating neurologist was out of town. They reported right frontal headache associated with blurred vision and nausea. The pt also reported that they feel like they will have a seizure and that they have been having jumping and jerking movements of their extremities which they commonly have just before they have a grand mal seizure. Neurologist programmed their device to rapid cycling. There was no mention of the heart palpitations in the notes from that office visit. Device diagnostic testing within normal limits, indicating proper device function. The pt was instructed to follow up with their treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=512380
« Last Edit: February 13, 2015, 12:19:14 AM by dennis100 » Logged
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« Reply #56 on: December 16, 2010, 12:52:33 AM »

Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization  
Event Description
Reporter indicated that vns pt was hospitalized because pt thought that they were having another heart attack. The pt had reportedly had a recent heart attack after which they underwent stent placement. Treating cardiologist reportedly found nothing wrong with the pt's heart and indicated that no treatment was given at the time that they had the heart attack that may have damaged the ncp system. The pt continues to experience a feeling of their heart pounding in their ears that sometimes awakens them from sleep. The pt also reports feeling this sensation in their neck and that they can feel their heart rate increase at times. These feelings are constant and do not coincide with device stimulation. Treating cardiologist reportedly indicated that he does not believe that the pt's symptoms are related to their recent heart attack. Treating neurologist indicated that the events were not related to the ncp system and that no intervention was planned. Neurologist indicated that the events were possibly cardiogenic. The pt reported that their device is programmed to the lowest possible setting (0. 25ma normal mode output current) and that they sometimes feel as if the device stimulates longer than it is supposed to. The pt experienced similar problems with heart palpitations in the past when device settings were increased, but that the problems resolved with a decrease in parameters.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=512577
« Last Edit: February 13, 2015, 12:20:31 AM by dennis100 » Logged
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« Reply #57 on: December 16, 2010, 12:53:30 AM »

Event Date 02/01/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Further follow-up revealed that the pt experienced a fall after having a breakthrough seizure and experienced a left shoulder injury. The pt indicated that she was hospitalized after experiencing chest pain with loss of consciousness. During hospitalization tested confirmed cardiac arrhythmia, but no cardiac structural abnormalities were evident. According to the pt, the physician declined to perform a cardiac cath due to the presence of the vns therapy system and attributed the pt's cardiac problems to vns therapy. Hosp physician also reportedly requested the pt to have the device programmed to off by treating neurologist. The pt is managed with holter monitoring. Treating neurologist plans to temporarily discontinue the device stimulation during the holter monitoring. Treating neurologist does not believe that the cardiac events are related to vns therapy because the pt had been implanted for approx 1 1/2 years without complication. The holter monitoring was performed and the pt reported that the monitoring showed that the arrhythmia is related to the device stimulation; however, it only occurred following magnet mode stimulation. The pt indicated that she does not want the device stimulation discontinued because of the efficacy she receives. The root cause of the reported event is unknown. The cause of the arrhythmia is possibly due to the lead becoming displaced during the pt's fall and becoming too close to the cardiac branches.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=515302
« Last Edit: February 13, 2015, 12:22:11 AM by dennis100 » Logged
dennis100
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« Reply #58 on: December 16, 2010, 05:58:07 AM »

Event Type Injury
Patient Outcome Life Threatening;
Event Description
Pt experiences muscle spasms down the left side of their body when they lie on their left side with their head elevated and their device stimulates. The pt underwent gall bladder surgery 1-2 weeks prior. The pt also reports pressure in their chest and difficulty exhaling. The pt was referred to a cardiologist for eval. Treating neurologist does not believe that the pt's symptoms are related to the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=523059
« Last Edit: February 13, 2015, 12:23:15 AM by dennis100 » Logged
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« Reply #59 on: December 16, 2010, 05:59:26 AM »

Event Date 02/01/2004
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Patient was experiencing shortness of breath and numbness radiating down their arm along with chest pain and pressure, not in the area of the vns. When patient feels these symptoms, patient "takes some nitro" and the symptoms resolve. Treating neurologist indicated that the reported event was not related to the vns therapy and may be related to the musculoskeletal or cardiac system. The patient was referred to a cardiologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=522091
« Last Edit: February 13, 2015, 12:23:59 AM by dennis100 » Logged
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